Pulmonary Thromboembolism in Cancer Patients: Early Rule-out From the Emergency Department

NCT06761144 | Recruiting

• 2 other identifiers: PS-23-01RC-2022-2773366
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief Summary

Pulmonary thromboembolism is a frequent complication of cancer; in some cases, it is diagnosed occasionally during diagnostic examinations as part of the regular follow-up of the disease. Not all patients diagnosed with thromboembolism present symptoms; therefore, after appropriate investigations during observation in the emergency room and/or a short hospitalisation in Emergency Medicine, they could be discharged home, avoiding lengthy hospitalisations that would have a considerable impact on their health and psychological condition. The goal of this observational study is to compare the efficacy of several assessment scales for use by physicians to identify patients at low risk of developing serious complications of pulmonary embolism within 30 days of diagnosis, in order to be able to identify a group of low-risk patients who could be discharged early from the emergency department/emergency medicine safely. What does participation in this study entail compared to the normal care you receive and what are your responsibilities as a participant? At the time of patient enrolment in the emergency room/emergency medicine, the data necessary for the calculation of 6 scoring systems will be collected, which will take approximately 5 minutes. The patient enrolled in the study will be contacted by telephone in order to assess the state of health; the call will take approximately 1 minute and will take place 30 days after access to the emergency room. Participation in the study does not entail any obligation or restriction, nor will it be charged for.

Conditions

Pulmonary Thromboembolisms

Outcome Measures

Primary Outcomes (1)

• Evaluate mortality in patients at low risk of major adverse events (death/respiratory failure/hospitalisation)

  The primary objective is to evaluate the already existing and used prognostic scores (HESTIA, PESI, sPESI, POMPE-C, EPIPHANY Index, RIETE) in cancer patients with incidental pulmonary embolism in order to identify the one with the greatest effectiveness for identifying patients at low risk of major adverse events at 30 days, who can therefore be discharged early and safely from the emergency department.

  From enrollment to the follow-up at 30 days

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with active oncohematological pathology, over 18 years of age, with a diagnosis of pulmonary embolism attending the Emergency Department of the IRCSS Azienda Ospedaliero-Universitaria di Bologna

You may qualify if:

• Age ≥ 18 years
• Diagnosis of pulmonary embolism (symptomatic and/or incidental)
• Active onco-haematological disease (disease followed in oncological/haematological and/or metastatic setting)
• Informed consent to the study

You may not qualify if:

• Patients returning to the Emergency Department for complications related to previously diagnosed pulmonary embolism

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

Eleonora Tubertini

Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Pulmonary Embolism

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Embolism; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Eleonora Tubertini, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eleonora Tubertini, MD

CONTACT

+39 051943435; eleonora.tubertini@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 1, 2024
• First Posted: January 7, 2025
• Study Start: July 13, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): July 1, 2027
• Last Updated: January 7, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)